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JACC VOL. 65, NO. 15, 2015

Letters

APRIL 21, 2015:1595–604

T A B L E 1 Patient Characteristics and Follow-Up (n ¼ 19)

Age, yrs

73.6  7.4

Male

13 (68.4)

Mean CHADS2 score

3.1  1.1

Mean CHA2DS2-VASc score

4.5  1.4

Mean HAS-BLED score

4.1  1.3

Post-Lariat anticoagulation*

1 (5.3)

Post-Lariat antiplatelet agents

4 (21.1)

Median time to clot detection, days

46 (17–428)

Location of clot Endocardial surface of the ligated site

1 (5.3)

Within the LAA through the leak into the LA

1 (5.3)

Anticoagulation started

*Center for Excellence in Atrial Fibrillation/ Complex Arrhythmia Management

17 (89.5)

Coumadin ridge Average clot size, mm

Rudolph Evonich, MD Abdi Rasekh, MD James Gray, MD Arun Mahankali Sridhar, MD Mathew Earnest, MD Ryan Ferrell, MD Jayant Nath, MD Yeruva Madhu Reddy, MD

11  10 19 (100)

Bloch Heart Rhythm Center University of Kansas Hospital KU Cardiovascular Research Institute 3901 Rainbow Boulevard MS 4023

7 (36.9)

Kansas City, Kansas 66160-7200

12 (63.2)

E-mail: [email protected]

Clot resolution‡

16 (84.2)

http://dx.doi.org/10.1016/j.jacc.2015.01.052

Mean time to clot resolution, days

91 (34–228)

Warfarin Novel oral anticoagulants†

Clinical stroke or thromboembolism

0 (0)

Major bleeding during follow-up

0 (0)

Minor bleeding during follow-up

1 (5.5)

Values are mean  SD, n (%), or median (range). *One patient was on oral anticoagulation but was noncompliant. †One patient was on antiplatelet agents but was switched to novel oral anticoagulants. ‡Three patients are still in follow-up. CHA2DS2-VASc ¼ congestive heart failure, hypertension, age $75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category; CHADS2 score ¼ congestive heart failure, hypertension, age $75 years, diabetes mellitus, stroke/transient ischemic attack; HAS-BLED ¼ hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly (>65 years), drugs/alcohol concomitantly; LA ¼ left atrium; LAA ¼ left atrial appendage.

receive antiplatelet or anticoagulant therapy during this period. The risk of LA thrombus in the absence of anticoagulation use post-procedure is low and is more

Please note: Dr. Lakkireddy has received speakers honoraria from Boehringer Ingelheim, Janssen, Pfizer, and Bristol-Myers Squibb; has served as a consultant for St. Jude Medical and BWI; and has received a research grant from SentreHEART. Drs. Gibson, Price, Valderrábano, Rasekh, and Earnest have received speakers honoraria from SentreHEART. Dr. Feldman has served as a consultant for Abbott, Boston Scientific, and Coherex; and has received research grants/honoraria from Abbott and Boston Scientific. Dr. Valderrábano has a relationship with Boston Scientific, St. Jude Medical, and Medtronic. Dr. Rasekh has served as a proctor for Lariat. Dr. Nath has received an honorarium from Lantheus Medical Imaging. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

REFERENCES 1. Gasparini M, Ceriotti C, Bragato R. Huge left atrial thrombus after left atrial appendage occlusion with a Watchman device. Eur Heart J 2012;33:1998. 2. Cruz-Gonzalez I, Martin Moreiras J, Garcia E. Thrombus formation after left atrial appendage exclusion using an Amplatzer cardiac plug device. Catheter Cardiovasc Interv 2011;78:970–3. 3. Bartus K, Han FT, Bednarek J, et al. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol 2013;62:108–18.

frequently seen during the first 3 months after LAA ligation. Periodic imaging studies are essential for early detection of an LA thrombus. With prompt initiation of anticoagulation and close supervision, an LA thrombus can be managed safely. *Dhanunjaya Lakkireddy, MD Ajay Vallakati, MD Arun Kanmanthareddy, MD Ted Feldman, MD Douglas Gibson, MD Matthew Price, MD David S. Rubenson, MD Jie Cheng, MD Miguel Valderrábano, MD Rajeev R. Fernando, MD Susan T. Laing, MD Eugene Chung, MD Sudharani Bommana, MPhil Donita Atkins, BS Jayasree Pillarisetti, MD Bradley P. Knight, MD

Do Clinical Trials In Ischemic Heart Disease Meet the Needs of Those With Ischemia? Since 1990, multiple randomized clinical trials (RCTs) and subsequent meta-analyses have compared the outcome of percutaneous coronary intervention (PCI) medical therapy for stable ischemic heart disease with no difference in primary outcome (death and/or myocardial infarction [MI]) between the 2 approaches. The reasons for this are not clear. It is certainly possible that there is no difference between the 2 strategies; alternatively, the patient populations may not have been appropriate, or the study hypothesis may not have been sufficiently focused on the right question. From 1980 until now, approximately 195,213 patients have been screened for enrollment in trials, of

JACC VOL. 65, NO. 15, 2015

Letters

APRIL 21, 2015:1595–604

reduce the risk of death, MI, or other major car-

F I G U R E 1 Percentage of Patients With Coronary

diovascular events when added to optimal medical

Atherosclerosis Included, Without Ischemia or Angina

therapy (OMT) in patients with stable ischemic heart disease. However, even the COURAGE trial

90

cannot be generalized to patients with a large ischemic

80

burden (1).

Percent

100

70

In 2009, the FAME investigators reported that PCI

60

guided by fractional flow reserve (FFR) could reduce

50

the incidence of cardiovascular events when com-

40

pared with angiographically guided PCI. The primary

30

endpoint (composite of major cardiac events) at 1

20

year occurred in significantly fewer patients in the

10

FFR-guided group than in the angiographic-guidance

0 FAME 2

COURAGE

ACIP

MASS2

AVERT

MASS

RITA2

RITA

ACME2

ACME

group (13.2% vs. 18.3%; p ¼ 0.02) (2,3). Recently, on the basis of the FAME I trial, De Bruyne et al. (4) hypothesized that in patients with stable CAD and stenosis, PCI performed on the basis of the FFR

Statistically significant (p < 0.0001) and wide variation between

would be superior to OMT. The 2-year follow-up

studies;

Do clinical trials in ischemic heart disease meet the needs of those with ischemia?

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